Annual Report for Fiscal Year 2016

NTP Impact on Regulatory Agencies

Federal and state regulatory agencies use NTP study data and recommendations in considering the need to regulate and test specific chemicals to protect human health. Below is a table highlighting the NTP data and recommendations used by other agencies in FY 2016. A full listing is also available on the NTP website.

Use of NTP Study Data or Recommendations by Federal and State Regulatory Agencies in FY 2016

Notice

Summary of Notice

NTP Information Cited

Chemical listed effective August 5, 2016, as known to the state of California to cause cancer: 1-bromopropane

Effective August 5, 2016, the Office of Environmental Health Hazard Assessment is adding 1-bromopropane (CASRN* 106-94-5) to the list of chemicals known to the state to cause cancer for purposes of Proposition 65.

Chemical listed effective July 29, 2016 as known to the state of California to cause cancer: bromodichloroacetic acid

Effective July 29, 2016, Office of Environmental Health Hazard Assessment is adding bromodichloroacetic acid (CASRN* 71133-14-7) to the list of chemicals known to the state to cause cancer for purposes of Proposition 65.

July 29, 2016 -- Proposition 65

National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CASRN 71133-14-7) in F344/N Rats and B6C3F1 Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

Chemical listed effective April 22, 2016 as known to the state of California to cause cancer: styrene

Effective April 22, 2016, Office of Environmental Health Hazard Assessment is adding styrene (CASRN* 100-42-5) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of styrene is based on formal identification by the National Toxicology Program, an authoritative body, that the chemical causes cancer. The criteria used by Office of Environmental Health Hazard Assessment for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306.

April 22, 2016 -- Proposition 65

National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, US Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391.

Final Rule: diflubenzuron; pesticide tolerances

Through this regulation the U.S. Environmental Protection Agency establishes tolerances for residues of diflubenzuron in or on multiple commodities. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act.

February 12, 2016 -- 81 FR 7466

PCA, a plant metabolite of diflubenzuron, tested positive for splenic tumors in the male rats and hepatocellular adenomas/carcinomas in male mice in a NTP study.

Final Rule: benzyl acetate; exemption from the requirement of a tolerance

Through this regulation the U.S. Environmental Protection Agency establishes an exemption from the requirement of a tolerance for residues of benzyl acetate (CASRN* 140–11–4), when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops only under 40 CFR 180.920. Technology Sciences Group, on behalf of the Huntsman Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act, requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of benzyl acetate.

February 12, 2016 -- 81 FR 7473

Because of the confounding effects of corn oil on the incidences of pancreatic neoplasm and because of the controversy over the use of the gavage route of administration, the NTP decided to re-study benzyl acetate using the dosed feed route of administration. In 1993, the NTP conducted a second set of carcinogenicity studies in rats and mice using the dose feed route of administration.

The point of departure for benzyl acetate is 110 mg/kg/day from the NTP 2-year carcinogenicity study in mice (dietary study) based on decreased in body weights in both sexes at the LOAEL of 345/375 mg/kg/day. There was no evidence of carcinogenicity in mice and rats.

The U.S. Environmental Protection Agency is adding 1-bromopropane to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990. 1-Bromopropane has been classified by the NTP in their 13th Report on Carcinogens as ‘‘reasonably anticipated to be a human carcinogen.’’ EPA has determined that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans.

November 23, 2015 -- 80 FR 72906

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition. Released October 2, 2015. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, U.S. Department of Health and Human Services. NIH Publication No. 13-5982, September 25, 2013

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